ARTISAN/VERISYSE MYOPIA PHAKIC INTRAOCULAR LENS

Lens, Intraocular, Phakic

FDA Premarket Approval P030028 S005

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for modifying the physician and patient labeling to include the results from the extended follow-up post-approval study.

DeviceARTISAN/VERISYSE MYOPIA PHAKIC INTRAOCULAR LENS
Classification NameLens, Intraocular, Phakic
Generic NameLens, Intraocular, Phakic
ApplicantOPHTEC BV
Date Received2017-01-23
Decision Date2018-08-20
PMAP030028
SupplementS005
Product CodeMTA
Docket NumberPremarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radia
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination Product No
Applicant Address OPHTEC BV 6421 Congress Ave,suite 112 boca Raton, FL 33487

Supplemental Filings

Supplement NumberDateSupplement Type
P030028Original Filing
S009 2022-02-08 30-day Notice
S008 2019-02-06 Real-time Process
S007
S006 2018-09-18 30-day Notice
S005 2017-01-23 Normal 180 Day Track No User Fee
S004 2017-01-31 Normal 180 Day Track No User Fee
S003 2012-01-05 30-day Notice
S002 2010-10-29 30-day Notice
S001 2009-11-25 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
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